Role OverviewSenior Manager / Associate Director, QualityWe are seeking a Senior Manager / Associate Director of Quality to own and execute the quality and compliance function of our organization as we scale from development into early manufacturing into commercialization.
This is a
full-time position. This is a hands-on, execution-focused leadership role responsible for building and owning Countable Labs' quality function. You will partner directly with R&D, engineering, manufacturing, and external partners (CDMOs and suppliers) to set quality strategy, drive execution, and establish the systems and culture needed for long-term regulatory readiness. While our current products are RUO, this leader will architect the quality infrastructure to support future IVD and regulated product pathways.
Quality Systems Support
- Build and own the quality management system (QMS) from the ground up, including document control, training, audit readiness, and design control procedures.
- Design and implement end-to-end complaint handling procedures, including intake, investigation, trending, and response.
- Own and govern document control, change control, and CAPA processes, ensuring consistent compliance across the organization.
- Define, track, and report on quality KPIs (e.g., internal and external defects, CAPA cycle time) to senior leadership; drive data-informed decisions for continuous improvement.
- Establish and oversee training programs and compliance requirements across all departments, ensuring readiness for internal and external audits.
- Implement and maintain robust quality event tracking systems to enable visibility, accountability, and proactive risk management across the organization.
- Lead post-market surveillance strategy, including feedback loop design, performance monitoring, and signal detection to inform continuous improvement and future regulatory submissions.
Contract Manufacturing Organization (CDMO) & Supplier Quality
- Lead qualification and ongoing quality management of the supplier and CDMO network, establishing a scalable supplier quality program.
- Direct supplier evaluations, audits, and performance monitoring; define risk-based selection criteria and corrective action expectations.
- Oversee review and disposition of supplier documentation including CoAs, deviations, and change notifications; establish escalation protocols and approval workflows.
- Define and enforce quality requirements through specifications, quality agreements, and supplier contracts; serve as the primary quality interface with external manufacturing partners.
Manufacturing & Quality Support
- Own the strategy and oversight of incoming inspection, in-process controls, and final product release, ensuring processes are scalable as manufacturing volume grows.
- Define and own product specifications and acceptance criteria in partnership with R&D and engineering; ensure documentation reflects current product state and regulatory intent.
- Lead investigations across nonconformances, deviations, and complaints; drive root cause analysis and ensure timely, effective corrective and preventive actions with appropriate escalation to leadership.
- Establish documentation and traceability standards for all builds and testing activities, ensuring audit-ready records at every stage of the product lifecycle.
- Drive resolution of supplier-related quality issues across cross-functional teams; own supplier corrective action requests (SCARs) and ensure timely closure.
Product Design & Development Quality
- Guide core teams on design control activities, including design inputs/outputs, verification, validation, and design reviews; serve as the quality authority in all product development gate decisions.
- Partner closely with R&D and engineering as a quality leader, ensuring requirements, specifications, and test plans are clearly defined, documented, and aligned with regulatory strategy from the start.
- Own approval and governance of development documentation (protocols, reports, design history file (DHF) content), maintaining a complete and inspection-ready DHF throughout the product lifecycle.
- Lead risk management activities (e.g., FMEA, risk assessments, hazard analysis) across product lines; ensure risk files are current, properly documented, and integrated into design and manufacturing decisions.
- Lead design transfer activities, defining readiness criteria and ensuring manufacturing processes, documentation, and quality controls are fully established prior to production scale-up.
Qualifications- Bachelor's degree in Life Sciences, Biotechnology, Engineering, or a related field.
- 7+ years of progressive experience in quality, with at least 3 years in a leadership or people management role within biotech, life sciences, or diagnostics.
- Proven track record of owning design control and product development quality from concept through launch, including DHF management.
- Demonstrated experience managing supplier quality and external manufacturing (CDMO) relationships, including audits, quality agreements, and corrective action programs.
- Deep expertise in quality systems and documentation practices (e.g., DHF, SOPs, change control, CAPA); experience building these systems in an early stage or startup environment strongly preferred.
- Strong command of risk management principles and tools (FMEA, hazard analysis, risk-benefit); able to drive risk decisions at an organizational level.
- Exceptional attention to detail with the ability to balance strategic thinking and hands-on execution in a fast-paced, resource-constrained startup environment.
- Excellent cross-functional leadership and communication skills; able to influence without authority, build quality culture, and represent the quality function at the executive level.
Preferred- Working knowledge of ISO 13485, FDA 21 CFR Part 820 (QSR/QMSR), and/or GMP, CE IVD, UK, CA, UL frameworks; experience preparing for or navigating regulatory inspections a plus
- Experience scaling quality systems from RUO or early-stage through IVD or regulated product development
- Exposure to instrumentation, software and/or reagent-based products
